The following data is part of a premarket notification filed by Advanced Medical Technology, Inc. with the FDA for Acridine Orange Fluorescent Stain.
| Device ID | K853187 |
| 510k Number | K853187 |
| Device Name: | ACRIDINE ORANGE FLUORESCENT STAIN |
| Classification | Acridine Orange |
| Applicant | ADVANCED MEDICAL TECHNOLOGY, INC. SUITE 502, PERIMETER PARK 3351 WRIGHTSBORO, RD. Augusta, GA 30909 |
| Contact | David A Wall |
| Correspondent | David A Wall ADVANCED MEDICAL TECHNOLOGY, INC. SUITE 502, PERIMETER PARK 3351 WRIGHTSBORO, RD. Augusta, GA 30909 |
| Product Code | IDC |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-08-13 |